Alaris Medical Systems
FDA adverse event reports naming Alaris Medical Systems as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ALARIS MEDICAL SYSTEMS.
- Total reports
- 1,121
- Deaths
- 21
- Injuries
- 187
- Malfunctions
- 869
Reports per year
Source: FDA adverse event reports by year received, 1999–2016. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Pump, InfusionFRN956
- Set, Administration, IntravascularFPA146
- Pump, Infusion, PcaMEA7
- Set, Blood TransfusionBRZ3
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ3
- Pump, Infusion, ElastomericMEB3
- System, Measurement, Blood-Pressure, Non-InvasiveDXN2
- Probe, Rectal, Non-PoweredEXX1
- Continuous Measurement ThermometerFLL1
- Needle, Hypodermic, Single LumenFMI1
Recent recalls
- 2005-03-03TerminatedOther
Model 8100 Series Medley Medication Safety System Pump Module
The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.
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